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Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas | Clinical Trials | Clareo Health

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Catumaxomab for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas

Explorative Trial to Investigate Catumaxomab (Anti-EpCAM x Anti-CD3) for Treatment of Peritoneal Carcinomatosis in Patients With Gastric Adenocarcinomas Prior to Gastrectomy

NCT01504256•AIO-Studien-gGmbH

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the efficacy of catumaxomab by determination of the rate of macroscopic complete remissions of peritoneal carcinomatosis after treatment with one cycle (four doses) of catumaxomab followed by six cycles of routine neoadjuvant chemotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Histologically confirmed diagnosis of resectable gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction (type II and type III according to Siewerts classification)
•Macroscopic peritoneal carcinomatosis (stage P1-4 according to Gilly et al., appendix 1)
•Patients potentially eligible for gastrectomy after primary systemic (and intraperitoneal) treatment
•Signed and dated informed consent before the start of specific protocol procedures
•Age \> 18 years
•ECOG Performance Status of 0 or 1
•Life expectancy of at least 12 weeks
•Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening
•* Hemoglobin \> 10.0 g/dl
•* Leukocyte count \> 4.000/μl; absolute neutrophil count (ANC) \> 2.000/μl
+6 more criteria

Exclusion Criteria

•Distant metastasis other than peritoneal seedings
•Prior diagnosis of any malignancy not cured by surgery alone less than 5 years before study entry
•Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = \< 1 year before enrolment
•History of HIV infection or chronic hepatitis B or C
•Active, clinically serious infections (\> grade 2 NCI-CTC version 3.0)
•Pre-existing neuropathy \> grade 1 (NCI CTCAE), except for loss of tendon reflex
•Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
•History of organ allograft
•Patients undergoing renal dialysis
•Known hypersensitivity to any of the drugs given in the study; known hypersensitivity to murine (rat and/or mouse) proteins
+7 more criteria

Locations (1)

Prof. Dr. F. Lordick

Leipzig, Germany

Key Dates

Start Date

October 1, 2011

Primary Completion Date

March 1, 2017

Completion Date

July 1, 2017

Last Updated

January 23, 2018

Enrollment

ESTIMATED participants

Conditions

Gastric Adenocarcinoma With Peritoneal CarcinomatosisSiewert Type II Adenocarcinoma of Esophagogastric Junction With Peritoneal CarcinomatosisSiewert Type III Adenocarcinoma of Esophagogastric Junction With Peritoneal Carcinomatosis

Interventions

catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel

DRUG

Fluorouracil, leucovorin, oxaliplatin, docetaxel

DRUG